A Study in Adults With Type 1 Diabetes (ELEMENT 1)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01421147
First received: August 19, 2011
Last updated: April 24, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: LY2963016
Drug: Lantus
Drug: Insulin Lispro
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open-label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Combination With Mealtime Insulin Lispro in Adult Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline up to 24 weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in insulin antibody levels [ Time Frame: Baseline, 6 weeks, 12 weeks, up to 24 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
  • Rate per 30 days of hypoglycemic episodes [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change in HbA1c [ Time Frame: Baseline, 6 weeks, 12 weeks, 36 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • 7-point self-monitored blood glucose (SMBG) profiles [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with HbA1c <7% and HbA1c ≤6.5% [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Glycemic variability of fasting blood glucose [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Insulin Dose per Body Weight (U/kg) (Total and by Component [Basal and Bolus]) [ Time Frame: Up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Insulin Dose - Units (Total and by Component [Basal and Bolus]) [ Time Frame: Up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks, up to 24 weeks, and 52 weeks ] [ Designated as safety issue: No ]
  • Adult Low Blood Sugar Survey (ALBSS) [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction Questionnaire (ITSQ) [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: No ]
  • Incidence of Hypoglycemic Events [ Time Frame: Baseline and up to 24 weeks and 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: August 2011
Study Completion Date: April 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2963016 + Insulin Lispro
LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with premeal insulin lispro. Insulin Lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks
Drug: LY2963016
Administered subcutaneously
Drug: Insulin Lispro
Administered subcutaneously
Active Comparator: Lantus + Insulin Lispro
Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with premeal insulin lispro. Insulin Lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks
Drug: Lantus
Administered subcutaneously
Drug: Insulin Lispro
Administered subcutaneously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have Type 1 Diabetes Mellitus based on the disease diagnostic criteria (World Health Organization [WHO] Classification)
  • Have duration of diabetes greater than or equal to one year
  • Have HbA1c less than or equal to 11.0%
  • On basal-bolus insulin therapy for at least 1 year (basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine)
  • Have a body mass index (BMI) of less than or equal to 35 kg/m^2

Exclusion Criteria:

  • Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
  • Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
  • Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
  • Have significant renal, cardiac, gastrointestinal or liver disease
  • Have active cancer or cancer within the past 5 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421147

  Hide Study Locations
Locations
United States, Alabama
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Birmingham, Alabama, United States, 35294
United States, Florida
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Hollywood, Florida, United States, 33021
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New Port Richey, Florida, United States, 34652
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West Palm Beach, Florida, United States, 33401
United States, Georgia
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Atlanta, Georgia, United States, 30303
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Roswell, Georgia, United States, 30076
United States, Illinois
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Springfield, Illinois, United States, 62704
United States, Iowa
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Des Moines, Iowa, United States, 50314
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Lexington, Kentucky, United States, 40503
United States, Louisiana
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Metairie, Louisiana, United States, 70006
United States, Michigan
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Kalamazoo, Michigan, United States, 49048
United States, Nebraska
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Omaha, Nebraska, United States, 68131
United States, New Hampshire
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Nashua, New Hampshire, United States, 03063
United States, New York
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Mineola, New York, United States, 11501
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New Hyde Park, New York, United States, 11040
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Syracuse, New York, United States, 13210
United States, North Carolina
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Asheville, North Carolina, United States, 28803
United States, Texas
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Austin, Texas, United States, 78731
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Dallas, Texas, United States, 75390
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San Antonio, Texas, United States, 78229
Belgium
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Brussels, Belgium, 1090
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
Germany
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Fulda, Germany, 36037
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Hamburg, Germany, 22607
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Heidelberg, Germany, 69115
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St. Ingbert-Oberwürzbach, Germany, 66386
Greece
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Athens, Greece, 11527
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Haidari/Athens, Greece, 12462
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Thessaloniki, Greece, 56429
Hungary
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Budapest, Hungary, 1134
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Debrecen, Hungary, 4032
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Salgotarjan, Hungary, 3100
Japan
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Fukuoka, Japan, 815-8555
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Kanagawa, Japan, 235-0045
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Kumamoto, Japan, 862-0976
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Miyazaki, Japan, 880-0034
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Nagasaki, Japan, 857-1195
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Tokyo, Japan, 105-8471
Mexico
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Guadalajara, Mexico, 44600
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Monterrey, Mexico, 64461
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Puebla, Mexico, 72190
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Tampico, Mexico, 89249
Poland
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Krakow, Poland, 31-530
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Lodz, Poland, 90-153
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Szczecin, Poland, 70-376
Romania
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Bucharest, Romania, 020359
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Galati, Romania, 800587
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Iasi, Romania, 700547
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Oradea, Romania, 410025
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Timisoara, Romania, 300182
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01421147     History of Changes
Other Study ID Numbers: 13712, I4L-MC-ABEB, 2011-000829-73
Study First Received: August 19, 2011
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for Protection Against Health Risks
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Agency for Medicines and Medical Devices
Russia: Ministry of Health of the Russian Federation

Keywords provided by Eli Lilly and Company:
Diabetes
Type 1 Diabetes
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014